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The purposes of this study is to test the safety of the study drug (FSR peptide) after a punch biopsy in healthy subjects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| FSR Peptide 20 μM | Experimental | Each subject will have two punch biopsies. FSR peptide will be applied to one punch biopsy. Placebo will be applied to the second punch biopsy. |
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| FSR peptide 50 μM | Experimental | Each subject will have two punch biopsies. FSR peptide will be applied to one punch biopsy. Placebo will be applied to the second punch biopsy. |
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| FSR peptide 100 μM | Experimental | Each subject will have two punch biopsies. FSR peptide will be applied to one punch biopsy. Placebo will be applied to the second punch biopsy. |
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| FSR peptide 200 μM | Experimental | Each subject will have two punch biopsies. FSR peptide will be applied to one punch biopsy. Placebo will be applied to the second punch biopsy. |
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| Placebo only | Placebo Comparator | Each subject will have two punch biopsies. Placebo will be applied to both punch biopsies. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| FSR Peptide 20μM | Drug | Administered immediately after punch-biopsy and 24 hours after punch biopsy. |
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| Measure | Description | Time Frame |
|---|---|---|
| Frequency of adverse events | Time of consent to day 28 |
| Measure | Description | Time Frame |
|---|---|---|
| Time to healing | The wound was clinically evaluated as healed or not healed. | Up to 28 days |
| Presence of hypertrophic granulation tissue | Clinically assessed as present or not present. To qualify as present, there should be at least 3 mm granulation tissue protruding above the edge of the wound at any point of its perimeter. |
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Inclusion Criteria:
Exclusion Criteria:
Symptoms of a significant somatic or mental illness in the two week period preceding drug administration.
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| Name | Affiliation | Role |
|---|---|---|
| Gautam Ghatnekar | CEO | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Swiss Pharma Contract Ltd | Allschwil | CH-4123 | Switzerland |
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| FSR Peptide 50μM | Drug | Administered immediately after punch-biopsy and 24 hours after punch biopsy. |
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| FSR Peptide 100μM | Drug | Administered immediately after punch-biopsy and 24 hours after punch biopsy. |
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| FSR Peptide 200μM | Drug | Administered immediately after punch-biopsy and 24 hours after punch biopsy. |
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| Placebo | Drug | Administered immediately after punch-biopsy and 24 hours after punch biopsy. |
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| Up to 28 days |
| Clinical General Impression scale on the evolution of the wound. | Scale of 1-5: 1- Very bad; 2- Bad; 3- Fair; 4- Good; 5- Very Good | Up to 28 days |
| Wound height | Assessed using the abbreviated Vancouver Scar Scale. The resulting abbreviated score was as follows. Scores are combined to calculate the final score. Pigmentation 0- Normal. Color that closely resembles the color over the rest of the subject's body
Vascularity 0- Normal. Color that closely resembles the color over the rest of the subject's body
| day 28 |
| Wound pliability | Assessed using the abbreviated Vancouver Scar Scale. The resulting abbreviated score was as follows. Scores are combined to calculate the final score. Pigmentation 0- Normal. Color that closely resembles the color over the rest of the subject's body
Vascularity 0- Normal. Color that closely resembles the color over the rest of the subject's body
| day 28 |
| Histopathological evaluation of the area of the scar tissue | Performed in a punch biopsy taken from the initial wound site at the end of the 28 day evaluation period. | day 28 |
| Histopathological evaluation of the epidermal involution | Performed in a punch biopsy taken from the initial wound site at the end of the 28 day evaluation period. | day 28 |
| Histopathological evaluation of the rete pegs | Performed in a punch biopsy taken from the initial wound site at the end of the 28 day evaluation period. | day 28 |
| Histopathological evaluation of the area of granulation tissue | Performed in a punch biopsy taken from the initial wound site at the end of the 28 day evaluation period. | day 28 |